Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device "ITC CERVICAL"
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-84
SponsorMT Ortho s.r.l.
About this trial
The goal of this observational post-market study is to evaluate the clinical performance and safety of the ITC CERVICAL device, a CE-marked implantable cervical interbody fusion cage, in adult patients undergoing anterior cervical discectomy and fusion (ACDF) for symptomatic cervical degenerative disc disease.
The main questions it aims to answer are:
1. Does the ITC CERVICAL device improve neck disability and pain after surgery? 2. Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes? 3. Is the device safe when used according to its intended purpose? Researchers will review retrospective clinical and radiological data from patients previously treated with the ITC CERVICAL device between 2020 and 2024. The outcomes assessed will include neck disability, pain intensity, neurological function, general health status, cervical lordosis, implant subsidence or migration, need for revision surgery, and the occurrence of adverse events.
Participants included in the study are adult patients who previously underwent two- or three-level ACDF surgery with implantation of the ITC CERVICAL device as part of routine clinical care. Clinical data collected before surgery, within 5 days after surgery, and at 3 months follow-up will be analyzed to assess the device's clinical benefits and safety profile.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant must be able to understand the nature, objectives, risks, and benefits of the study and provide free and informed consent, in accordance with current regulations.
Patients undergoing primary ACDF (Anterior Cervical Discectomy and Fusion) at two or three (contiguous) levels between C2 and C7
Diagnosis of symptomatic degenerative disc disease, including: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis
Availability and reliability of the neurological examination and pre- and post-operative clinical and radiological data and medical history
Disqualifiers
Patients undergoing primary ACDF on a single level between C2 and C7
History of previous surgeries in the anatomical area of interest
Trial population
The subjects involved are patients with cervical disc disease or symptomatic degenerative disc disease, stenosis, radiculopathy and/or spondylosis, treated with cervical cages, aged \>18 years
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Neck Disability Index (NDI)
Time frame
From enrollment (which corresponds with the performance of the surgery) within 3 months of the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: